India Pharma Outlook Team | Tuesday, 23 September 2025
Johnson & Johnson today reported the results of new Phase 3 data for seltorexant, a novel selective orexin-2 receptor antagonist, as an add-on treatment for adults and elderly patients with major depressive disorder (MDD) and insomnia symptoms.
The results were presented at the U.S. Psychiatric and Mental Health Congress that was held in San Diego, September 17-21. This randomized, double-blind, 26-week trial compared seltorexant to quetiapine extended release (XR), a well-known add-on treatment.
Although the study did not achieve statistical significance on its primary endpoint, seltorexant showed a numerically higher response rate than quetiapine XR (57.4% vs 53.4%) and showed similar improvement in depressive symptoms, as assessed using the Montgomery-Asberg Depression Rating Scale (MADRS).
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Notably, seltorexant was better tolerated than quetiapine XR, and produced substantially fewer side effects. Somnolence was reported in only 6% of participants receiving seltorexant compared with 24% with quetiapine XR, and the average weight gain for the seltorexant group was 0.5 kg compared with 2.1 kg for the quetiapine XR group. Seltorexant was also associated with a greater number of participants remaining on treatment for the entire 26-week treatment period.
Industry experts point out that depression and insomnia often exacerbate one another, leading to worse overall outcomes. Currently, there is no approved treatment that addresses both conditions, even though almost 60% of patients diagnosed with MDD experience insomnia that continues even with antidepressant treatment. Johnson & Johnson indicated that seltorexant could address this important treatment gap by providing significant symptom relief with less sampling tolerability issues and represents a potential first-in-class treatment in psychiatry.
